An observational study in Platelet Function Tests, Thrombin Generation Tests and Perioperative Coagulopathy, sponsored by The Hospital for Sick Children. Status unknown at 1 site in Canada. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by The Hospital for Sick Children · Observational
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's planned enrollment of 130 is above the median of 100 across 229 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry
Postoperative chest tube blood loss
Time frame: 24hr
Postoperative chest tube blood loss
Time frame: 6hr
Postoperative chest tube blood loss
Time frame: 12hr
Transfusion of blood products
Time frame: 24hr
All-cause mortality
Time frame: within 30 days
Length of hospital stay
Time frame: through study completion, an average of less than one month
Length of ICU stay
Time frame: within 30 days
Duration of mechanical ventilation
Time frame: within 30 days
Inotropes
Duration of inotropic support
Time frame: within 30 days
Kidney injury
Acute kidney injury
Time frame: within 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children